From the wires: The FDA has just completed a fresh set of guidelines that will permit pharmaceutical companies to tell doctors about unapproved uses of their medicines—in effect, giving big pharma carte blanche to hawk unapproved drugs.
Specifically, the new regulations allow drug companies to “distribute copies of medical journal articles that describe unapproved uses” of their drugs to all the doctors they want.
Technically this reg isn’t new; it was in place until 2006, then lapsed until industry lobbyists made sure it was proposed again last year, despite heavy criticism from Democrats and drug industry critics. And now, conveniently one week before the Bush administration draws its final, sputtering breath, the rule has made its way back into the final FDA guidelines.
Big pharma spokespeople pooh pooh the reg as nothing more than a formality: “Physicians need timely access to the latest medical information to keep abreast of the best practices in patient care,” said Alan Bennett, an attorney representing the pharmaceutical industry.
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What would happen if the U.S. government announced a new obesity-fighting initiative whereby every chronically obese person in the country was given up to two federally-funded Big Macs a day? That’s basically the plan of attack Switzerland is taking with its heroin addicts. The BBC reports that the Swiss have passed a “radical” health policy that allows long-term addicts to receive the drug at government clinics, free of charge.
A whopping sixty-eight percent of voters supported the policy, which would allow addicts to inject the drug up to twice a day under medical supervision. Granted, the scheme has some benefits: it increases control of needle use and disposal, provides incentives for addicts to come into clinics regularly and be treated for other medical or psychological problems, and removes the need for them to resort to crime to pay for their habit. Part of the bill’s popularity also comes from the fact that the scheme has already been underway in Zurich for 14 years, and many consider it successful.
Still, at the end of the day, the bill is exactly what it sounds like: a plan to have the government pay to shoot its citizens up with expensive and extremely dangerous drugs.
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Here’s some news that could put an interesting twist in the gambling addiction/genetics debate (not to mention supply new reasons to sue drug companies): ABC News reports that several of the drugs prescribed for Parkinson’s disease and restless legs syndrome can cause a range of dangerous behavioral side effects including increased drinking, drug use, risky sex, and gambling.
The drugs, which include Mirapex and Requip, are dopamine agonists, which mimic dopamine in the brain to boost the movement and coordination centers—and also stimulate the pleasure response by reinforcing certain behaviors. Unwitting patients who’ve taken the drugs have wound up with costly gambling habits, DUI arrests, and compulsive eating disorders, as well as even stranger effects—one man reportedly plays basketball for up to 36 hours at a time, while another compulsively fishes.
Given that more than 10 million prescriptions have been written for Mirapex alone, it’s not unlikely that we’ll see some serious fallout, be it motorists killed by a drunk driver on the drug, or an STD spike as a result of risky sexual practices (which are already on the rise among seniors, the demographic most likely to be taking meds for Parkinson’s and RLS).
As such, it’s worth it to start asking to what degree patients should be held legally responsible for their actions while taking the drug—and, perhaps even more importantly for lawyers, whether the drug companies can be held at all responsible for all that irresponsible boozing and sex.
